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|Place of Origin:||Hubei,China|
|Minimum Order Quantity:||10gram|
|Packaging Details:||Foil bag|
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|Keywords:||Chondroitin Sulfate||Alias:||Chondroitin Sulphate|
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|Export Market:||USA, UK, Brazil, Thailand, Canada||Policy:||Reshipping Policy|
local anesthetic powder,
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Pharmaceutical Ingredient Chondroitin Sulfate Chondroitin Sulphate CAS 9007-28-7
1.Cetrificate:GMP DMF HALAL ISO
2.Test: HPLC CPC
3.Standard: BP USP EP FCC
4.Original: Marine, Bovine, Chicken Duck Bovine Blend
5.Appearance: White to Light Yellow Powder
7. Pacakge: 25 kg/drum, 10000kg 1*20gp
8. Shelf life: 2 years
Chondroitin sulfate is a sulfated glycosaminoglycan (GAG) composed of a chain of alternating sugars (N-acetylgalactosamine and glucuronic acid). It is usually found attached to proteins as part of a proteoglycan. A chondroitin chain can have over 100 individual sugars, each of which can be sulfated in variable positions and quantities. Chondroitin sulfate is an important structural component of cartilage and provides much of its resistance to compression. Along with glucosamine, chondroitin sulfate has become a widely used dietary supplement for treatment of osteoarthritis.
Although chondroitin is used in dietary supplements as an alternative medicine to treat osteoarthritis and also approved and regulated as a symptomatic slow-acting drug for this disease (SYSADOA) in Europe and some other countries, it is technically neither a medicine nor a disease-modifying treatment. See Clinical effects below. It is commonly sold together with glucosamine. Chondroitin and glucosamine are also used in veterinary medicine. Formulated with collagen and wound dressing matrix, one product that uses chondroitin sulfate is the veterinary wound gel Chondroprotec, which is applied over scrapes, burns, and lesions and serves to keep the wound moist and promote healing.
Chondroitin, along with commonly used glucosamine, should not be used to treat patients who have symptomatic osteoarthritis of the knee as evidence shows that these treatments fail to provide relief for that condition.
Clinical studies have not identified any significant side effects or overdoses of chondroitin sulfate, which suggest its long-term safety. The Task Force of the European League Against Rheumatism (EULAR) committee recently granted chondroitin sulfate a level of toxicity of 6 in a 0-100 scale, confirming it is one of the safest drugs for osteoarthritis. Moreover, its safety is supported by an absence of drug-drug interactions (chondroitin sulfate is not metabolized by cytochrome P450), and the lack of safe alternatives for patients multi-medicated for osteoarthritis and other accompanying diseases, e.g. diabetes, hypertension, hyperlipidemia, etc.
Chondroitin sulfate chains are linked to hydroxyl groups on serine residues of certain proteins. Exactly how proteins are selected for attachment of glycosaminoglycans is not understood. Glycosylated serines are often followed by a glycine and have neighboring acidic residues, but this motif does not always predict glycosylation.
Attachment of the GAG chain begins with four monosaccharides in a fixed pattern: Xyl - Gal - Gal - GlcA. Each sugar is attached by a specific enzyme, allowing for multiple levels of control over GAG synthesis. Xylose begins to be attached to proteins in the endoplasmic reticulum, while the rest of the sugars are attached in the Golgi apparatus.
The effect of chondroitin sulfate in patients with osteoarthritis is likely the result of a number of reactions including its anti-inflammatory activity, the stimulation of the synthesis of proteoglycans and hyaluronic acid, and the decrease in catabolic activity of chondrocytes inhibiting the synthesis of proteolytic enzymes, nitric oxide, and other substances that contribute to damage cartilage matrix and cause death of articular chondrocytes. A recent review summarizes data from relevant reports describing the biochemical basis of the effect of chondroitin sulfate on osteoarthritis articular tissues. The rationale behind the use of chondroitin sulfate is based on the belief that osteoarthritis is associated with a local deficiency or degradation of natural substances, including internal chondroitin sulfate.
Recently, new mechanisms of action have been described for chondroitin sulfate. In an in vitro study, chondroitin sulfate reduced the IL-1β-induced nuclear factor-kB (NF-κB) translocation in chondrocytes. In addition, chondroitin sulfate has recently shown a positive effect on osteoarthritic structural changes occurred in the subchondral bone.
A review published in the Annals of Rheumatic Diseases describes all the documented evidence regarding the mechanisms of action of chondroitin sulfate.
Most chondroitin appears to be made from extracts of cartilaginous cow and pig tissues (cow trachea and pig ear and nose), but other sources such as shark, fish, and bird cartilage are also used. Since chondroitin is not a uniform substance, and is naturally present in a wide variety of forms, the precise composition of each supplement will vary. In fact, although many food supplement companies produce their products in compliance with human food processing Good Manufacturing Practice (GMP), most of them do not produce their products in compliance with the GMP regulations for pharmaceuticals, resulting in products without pharmaceutical requirements. Companies have attempted to produce chondroitin from other substances but have not yet had success.
Recent testing has revealed several flaws in the older testing methods. Without knowing the source of the chondroitin (e.g., shark, porcine, or bovine) and the approximate age of the animal, it is impossible to get a reliable reference standard, and, thus, results from previous testing had yielded percentages between 50 and 400%. In 2007, David Ji et al. reported in the Journal of Analytical Chemistry an extremely accurate method of quantification. The method included using an enzyme to break the chondroitin into its individual unsaturated disaccharides, and then measuring them using HPLC with an ion-pairing column and UV detection.
In general, doses of 200-400 milligrams have been taken by mouth 2-3 times daily, or 800-1,200 milligrams once daily. Higher doses (up to 2,000 milligrams) may have similar effectiveness. For osteoarthritis, full effects may take several weeks to occur.
To treat bone diseases, 600 milligrams of chondroitin sulfate (Green Pharmaceutical Factory of Chongqing, China) have been taken by mouth twice daily for six months.
To treat coronary artery disease, 4.5 grams of chondroitin have been taken by mouth for 64 months. A dose of 1.5-10 grams has been taken by mouth daily for six years. Chondroitin sulfate A has been injected into the vein at a dose of 5 milligrams per kilogram of body weight. Chondroitin sulfate C has been injected into the vein at doses of 10-20 milligrams per kilogram of body weight.
To treat osteoarthritis, the most common dose is 200-400 milligrams taken by mouth 2-3 times daily (daily dosages of 800-2,000 milligrams appear to have similar effectiveness). Treatment durations have ranged from three weeks to three years. A dose of 100 milligrams of Matrix® has been injected into the vein daily. Chondroitin has been injected into the muscle daily for six weeks or two 13-week intervals. Chondroitin has been injected into the muscle twice weekly.
|Appearance||Off white to creamy powder (Visual)||USP29 -- <695>|
|Bulk Density||NLT0.55g/ml||USP29 -- <616>|
|As Tapped Density||Meets the requirements of USP29||USP29 -- <616>|
|Assay (HPLC)||More than 90%||HPLC|
|A: Infrared Absorption||Meets the requirement||A: USP29 -- <197K>|
|B: Tests for Sodium||Meets the requirement||B: USP29 -- <191>|
|Absorb||<0.35a.u. (5.0% Water Solut.-420nm)||USP29 -- <197>|
|Specific Rotation[a]D20||minus20.0°-- minus30.0°||USP29 -- <781S>|
|PH (1%H2O solution.)||5.5-7.5||USP29 -- <791>|
|Loss on Drying||NMT10%||USP29 -- <731>|
|Residue on Ignition||NMT20%-30% (dry base)||USP29 -- <281>|
|Chloride (Cl)||NMT 0.5%||USP29 -- <221>|
|Sulfate||NMT 0.24%||USP29 -- <221>|
|Heavy Metals||NMT 20 ppm||USP29 -- <231>II|
|Iron (Fe)||NMT 10 ppm||USP29 -- <241>|
|Lead||NMT 0.5 ppm||AFS|
|Arsenic (As)||NMT 3.0 ppm||USP29--<211>II|
|Mercury||NMT 0.5 ppm||AFS|
|Organic volatile impurities||Meets the Requirements||USP29 -- <467>I|
|Total Bacteria Count||NMT 1,000 cfu/g||USP29 -- <61>|
|Yeast & Mold||NMT 100 cfu/g||USP29 -- <61>|
|E. Coli||Negative||USP29 -- <61>|
|Salmonella||Negative||USP29 -- <61>|
|Staphylococcus Aureus||Negative||USP29 -- <61>|
|Conclusion:||Meets USP 29 standards|
|Packaging and Storage:||Store in tight, containers under 25°C|
|Reason for Change:||Updating Specification Format to USP 29|
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